More E. coli testing may be just days away, or it could be well past March 5 before we know how all this is going to come out.

Since the USDA Under Secretary for Food Safety, Dr. Elisabeth Hagen, announced on Sept. 13 that six more strains of pathogenic Shiga toxin-producing Escherichia coli would be banned from ground beef, the process has taken over.

The so-called “Big Six,” Hagen said, will be considered adulterants in ground beef, just as E. coli O157:H7 has since 1994. The six additional pathogenic strains are O26, O45, O103, O111, O121 and O145.

Starting March 5, beef processors should begin testing for those six and O157 in beef trim, which is used in ground beef. Testing ground beef will follow. Meanwhile, USDA’s Food Safety and Inspection Service (FSIS) has gone through a rule-making process complete with public comments.

The comment period, originally scheduled for 60 days but expanded to 90 at the behest of the beef industry, officially ended Dec. 21. Comments from an FSIS-hosted Dec. 1 teleconference were also added to the written record.

Foreign governments, industry groups, consumer and environmental advocacy organizations, and technical organizations were among those filing comments.

While the beef industry badly wants the testing start date postponed, and there are questions about the sufficient availability of certified testing kits, FSIS is committed to kicking off on March 5, according to the agency’s top non-political appointee, Administrator Al Almanza.

When industry representatives asked for delay, Almanza gave them more time for comment, but re-committed to the March 5 start date.     

Still, all the comments add up to a lot of disagreement, and those disputes may be fought out in several venues over the months ahead. That could involve everything from arcane challenges filed with the World Trade Organization to influencing the outcome of the 2012 elections.

In the meantime, here’s the rundown on where various parties stood Dec. 21 at the deadline for comments:                                                                                                                                                                                                      

Domestic Concerns

In a year when the cost of government regulation is sure to be blamed by some for job loss, the cost of banning more E. coli from meat is certain to get attention.

To say there is a bit of a gap in estimates of those costs is to put it mildly.

USDA figured the cost of screening for more strains of pathogenic E. coli in beef, and diverting any contaminated beef to cooked products, will cost the $155 billion beef industry an extra $10 million a year. 

Not so, fast, says the industry’s Beef Industry Food Safety Council, an arm of the powerful National Cattleman’s Beef Association based in Denver. It puts the annual cost of the new regulations at $173- to $323 million. 

“These totals include costs to production, laboratory testing, added costs for recalls and diverted product, ” commented J.O. “Bo” Reagan, who chairs BIFCO. The beef industry’s cost impact analysis is detailed, looking like something that might have fallen out of a submission to the IRS.

By the pound, the most comments about the new testing came from the Washington D.C.-based American Meat Institute, whose members slaughter and process more than 90 percent of U.S. beef. Jim Hodges, AMI executive vice president, and Mark Dopp, general counsel, submitted 225 pages.

The AMI cost estimate for implementing the new testing scheme is $72- to $144 million annually.

In the run-up to the policy announcement last September, and since, AMI has been nothing if not consistent in its concerns. It wants a baseline survey and a “viable analytical laboratory test method” before any more testing goes forward.

In the Dec. 1 teleconference, Hodges cited “enormous knowledge gaps that exist” and said there is a “lack of a solid foundation” for the new policy, which it does not think is necessary.

“The available public health data do not indicate that these particular STEC pose an unusual or urgent public health challenge,” Hodges said.  “To our knowledge, one outbreak in the U.S. involving three individuals has been associated with non-O157 STEC in ground beef.”

The AMI also makes the case that E. coli O157:H7 is “a logical index organism for STEC in ground beef and the component that make up ground beef products.”  It also contends the interventions the industry uses to control O157 are also effective in controlling STEC.

So far, AMI has not approached the federal courts as it did when trying to block the O157 listing in 1994; but that’s a move that could still be in the organization’s playbook.

Foreign Concerns

Australia, Canada and New Zealand, all counties importing beef to the United States, wrapped their comments around their big gun, namely that testing for more strains of E. coli may violate trade agreements under the World Trade Organization.

The way these beef exporting countries see it, the U.S. has not provided enough evidence of non-O157 contamination to justify the new FSIS rule and new import requirements.

In its very polite comments, the Government of New Zealand calls for a “thorough risk assessment” as required under Article 5 of the WTO Sanitary and Phytosanitary Agreement that “clearly and irrefutably demonstrates the public health ramifications of nonO157 STECs on beef.”

“The assessment should clearly demonstrate that the U.S. is not inadvertently erecting a non-tariff trade barrier,” New Zealand said.

AMI also played the WTO card on behalf of its members in Australia, Brazil and Canada by asserting that the new FSIS rule “likely contravenes” trade agreements.

AMI says our trading partners do not view non-O157 STECs as a public health hazard and infections that do occur “are attributed to non-beef food sources.”

The powerful Washington D.C.-based “big beef” lobby also says a risk assessment is required under Article 5 of the WTO agreement.

AMI said it learned during the Dec. 1 public teleconference held by FSIS that several foreign governments share these concerns. Those governments could ultimately appeal and win at the WTO level, as Canada and Mexico recently did with the U.S. Country of Origin Labeling (COOL) law passed by the U.S. Congress in 2008.

The Reston, VA-based Meat Import Council of America, a trade association that represents U.S. businesses importing fresh, chilled and frozen beef, wants testing for the six additional E. coli strains delayed until both baseline studies are completed and an adequate supply of validated commercial test kits is available to overseas packers for at last three months.

Public Concerns

Food & Water Watch, the Washington D.C.-based non-profit consumer organization, was concerned about what it heard during the Dec. 1 stakeholders teleconference. Wenonah Hauter, the group’s executive director, wrote, …”We were taken aback by some of the foreign governmen
t representatives who claimed there was no need for this new policy.”

“There have been foodborne illness outbreaks in some of these countries involving the pathogens covered by this policy,” she continued. “Specifically, Australia has experienced outbreaks attributed to meat products contaminated with E. coli O111.”

Food & Water Watch noted that the U.S. imported 564 million pounds of red meat from Down Under in 2010 and U.S. consumers need to be protected from these pathogens.

Hauter called the process that FSIS has already gone through “tortuous” and predicted the March 5 implementation date can be met with “minimal controversy.”

The Center for Foodborne Illness Research & Prevention disagreed with the foreign government argument that non-O157 strains are not their problem.

CFI co-founders Barbara Kowalcyk and Patricia Buck pointed to research by Martina Bielaszewska at the University of Munster showing that almost half the cases of hemolytic uremic syndrome (HUS) in Germany from 1996-2006 were caused by non-O157 STECS.

“Further, according to data collected by EnterNet, a global surveillance consortium involving 35 countries, non-O157 STEC increased globally by 60.5 percent between 2000 and 2005, while O157 STEC only increased 13 percent during the same period,” they wrote.

CFI says non-O157 strains predominate in several countries, including Australia, Uruguay, Brazil, German, and the United Kingdom, including many countries that are big sellers of beef to the U.S.

The Center for Science in the Public Interest also weighed in, urging FSIS to designate the pathogenic STECs as hazards that are reasonably likely to occur.

“In 2008, a private laboratory conducted a nationwide sample survey of retail ground beef and found that the presence of non-O157 STECs was more common than Salmonella in the samples, specifically, of the 5,070 tests, there were 96 confirmed positive results for non-O157 STECs and 86 confirmed results for Salmonella.”

CSPI said that until 2002, O157:H7 was not designated as a hazard reasonably likely to occur, eight years after it was declared an adulterant in meat. “We see no compelling reason for a similar delay, and urge the agency to designate STEC as reasonably like to occur at all stages of handling raw beef products now.”

CSPI in 2011 petitioned FSIS to ban four Salmonella strains in meat, because humans who become infected with them are known to resist antibiotics. The organization does not think the availability of test kits will be a barrier to the March 5 implementation date.

The National Consumers League asked that the March 5 start date not be delayed in any way, and recommended the testing expand from raw beef trim to ground beef as rapidly as possible. The Washington D.C.-based organization said non-O157 STEC infections reported on the FoodNet system increased by five times between 2000 and 2007.

Michael Hansen, senior scientist for Consumers Union, said the advocacy group agrees with USDA’s reasoning in making the Big Six adulterants because the same four conditions were considering in declaring O157:H7 an adulterant. Those include: 1) The pathogen is not killed by traditional and accepted cooking practices; 2) Only a small number of bacteria can cause  illness; 3) The illness can result in severe, life-threating damage to major organ systems especially in children and elderly; and 4) The pathogens can spread person to person.

Technical Concerns

The American Proficiency Institute (API) asked FSIS to require that examining laboratories submit to proficiency testing for non-O157 STEC.  FSIS has developed a laboratory methodology for detection and isolation of the Big Six strains.

API, which claims to be the largest proficiency testing service for U.S. food laboratories with 600 customer labs, says 7.5 percent of the time, E. coli O157:H7 is missed in testing.

“If laboratories were unable to determine correctly if pathogens are present in food, then the front line of providing a safe food supply has failed us,” API President Daniel C. Edson said.

Finally, Neogen Corporation is concerned about nomenclature.   

“We believe the Agency has talked about O groups as adulterants in an attempt to simplify the issue for all stakeholders,” said Neogen’s Melissa Herbert, industry affairs director.  “However, in doing so, we feel that the rule, as written, has confused many stakeholders with regard to the Agency’s true intent.”

Herbert says Neogen understands the regulator’s intent is not to consider a sample adulterated unless is contains a bacterium that tests positive for one of the 6 “O” group markers, plus Shiga toxin (stx) and intimin (eae) and is biochemically confirmed to be E. coli.